Satisfying the safety of an assembly system

Those products which administer medication for inhalation or injection must exhibit an absolute level of safety – both for the user and for the medication. Criteria, based upon the requirements of the US Food and Drug Administration, to ensure this safety have been developed by the pharmaceutical and medical device industry.

Naturally, this requirement influences the concept of the assembly system. The basics are that it must function in a cleanroom, typically of class 10,000, and for this reason, it is necessary to separate the assembly area from any mechanical machinery parts by a medical guarding. This working area must also be designed in such a way that inaccessible zones, which may collect particles that could potentially pollute the product to be assembled, are eliminated. To prevent product contamination, this area will require frequent cleaning too and the working area design should allow easy access for these procedures. Materials that resist corrosion from aggressive cleaning solutions, such as stainless steel, are vital in this environment. System components should also be sealed and have life-time lubrication systems. Finally, if necessary, the system should be fitted with a laminar flow air extraction system.

GAMP guidelines The GAMP (Good Automated Manufacturing Practice) guidelines were established for users and suppliers of automatic machines and assembly systems. These allow pharmaceutical companies to define a standard of manufacture and documentation for medical products, which should be followed to achieve FDA validation for the products. To obtain the FDA release, the customer must demonstrate that an assembly system functions correctly in accordance with the specifications and that the product is of the quality demanded. This requires full and comprehensive documentation. The release to production is awarded in accordance with a qualification process, which comprises the following four phases: 1. Design Qualification (DQ) 2. Installation Qualification (IQ) 3. Operational Qualification (OQ) 4. Performance Qualification (PQ)

Successful qualification At Mikron, the whole of the qualification support system is standardised and integrated in the project procedure (see Project Procedure table). By providing "qualification support" the customer saves an enormous amount of time during the validation process and the time-to-market and time-to-volume parameters are accordingly reduced.